Biogen IDEC files rFVIII Fc at FDA for treatment of Haemophilia A

Biogen Idec has announced that the company has submitted a Biologics License Application (BLA) to the FDA for the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of Haemophilia A. Recombinant FVIIIFc is the first Haemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of reducing the burden of treatment for this condition. If approved, rFVIIIFc will be the first major advance in Haemophilia A treatment in more than two decades. The regulatory submission was based on results from A-LONG, the largest registrational phase III clinical study in Haemophilia A to date.

In the phase III study, patients treated with rFVIIIFc were able to inject rFVIIIFc once-weekly to twice-weekly, which creates the potential for those currently on prophylactic treatment to reduce injections by 50 to 100 per year. Moreover, patients currently treating bleeding episodes could potentially dose prophylactically once per week and maintain significant protection from bleeding with about the same total number of injections each year they use to treat bleeding episodes today.